Prosecution Insights
Last updated: May 29, 2026
Application No. 17/911,089

NEUROTOXIN COMPOSITIONS FOR USE IN TREATING CARDIOVASCULAR DISORDERS

Non-Final OA §102§103§112
Filed
Sep 12, 2022
Priority
Mar 12, 2020 — provisional 62/988,764 +1 more
Examiner
JACKSON-TONGUE, LAKIA J
Art Unit
1645
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Aeon Biopharma Sub Inc.
OA Round
3 (Non-Final)
69%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
89%
With Interview

Examiner Intelligence

Grants 69% — above average
69%
Career Allowance Rate
464 granted / 674 resolved
+8.8% vs TC avg
Strong +20% interview lift
Without
With
+20.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
21 currently pending
Career history
714
Total Applications
across all art units

Statute-Specific Performance

§101
1.7%
-38.3% vs TC avg
§103
41.2%
+1.2% vs TC avg
§102
28.5%
-11.5% vs TC avg
§112
21.3%
-18.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 674 resolved cases

Office Action

§102 §103 §112
Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . DETAILED ACTION Continued Examination Under 37 CFR 1.114 1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 21, 2026 has been entered. Claims 39-68 are currently pending. Claims 39, 42-43, and 53 have been amended. Claim 52 was previously withdrawn from consideration as being drawn to a non-elected invention. Claims 39-51 and 53-68 are currently under examination. Rejections Withdrawn 2. In view of Applicant’s response, the rejection of claim(s) 48-49, 58-59 and 64-65 under 35 U.S.C. 103 as being unpatentable over Carroll et al., US 2007/0264373 A1; Published: Nov. 15, 2007 as applied to claims 39-47, 50-55, 57 and 61-68 above, and further in view of Bright et al., US 2019/0038646; Published: 2/7/19 is withdrawn. Rejections Maintained Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 3. The rejection of claim(s) 39-47, 50, 51, 53-55, 57, 61-63, and 66-68 under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Carroll et al., US 2007/0264373 A1; Published: Nov. 15, 2007 is maintained for the reasons set forth in the previous office action. Independent claim 39 is drawn to a method of treating a cardiovascular disorder comprising: administering a botulinum toxin into the stellate ganglion of a mammal to treat at least one of angina, arrhythmias of heart rate, a myocardial contractility disorder, coronary artery disease, and high blood pressure; thereby reducing the occurrence of at least one symptom of the disorder. Independent claims 42 is drawn to a method of treating a cardiovascular disorder comprising: administering a botulinum toxin into the stellate ganglion in a subject with a cardiovascular disorder to thereby treat their symptoms. Independent claim 43 is drawn to a method of treating a cardiovascular disorder comprising administering a botulinum toxin into the stellate ganglion wherein the administration is performed by imaging the treatment area. Independent claim 53 is drawn to a method of treating a cardiovascular disorder comprising the steps of administering a botulinum toxin into the stellate ganglion nerve of a mammal to treat at least one of arrhythmias of heart rate, a myocardial contractility disorder, coronary artery disease, and high blood pressure; and administering a local anesthetic to the stellate ganglion nerve of said mammal, thereby reducing the occurrence of at least one symptom of the disorder. Carroll discloses methods to extend sympathetic nerve block, by administration of a neurotoxin at and/or around a targeted sympathetic ganglion. A preferred neurotoxin is a botulinum toxin, e.g. serotypes A, B, C1, D, E, F and G. The neurotoxin may be administered percutaneously as one or a cocktail of serotypes; and is optionally combined with a local anesthetic, anti-inflammatory agent, and the like (see paragraph 0019; meets limitations of claim 39, 42-43, 54 and 68). In one embodiment of the invention, the toxin used to induce sympathetic block is used for the treatment of sympathetically maintained pain. In this method, the involvement of sympathetic nerves may be initially diagnosed through a short term sympathetic block, for example by administration of an IV adrenergic antagonist; percutaneous administration of local anesthetic near the sympathetic ganglion or chain, and the like. Following confirmation of sympathetic involvement in pain, the neurotoxin is administered to the targeted sympathetic ganglion (see paragraph 0020; meets limitations of claim 39, 42-43 and 68). In one embodiment, a block of the upper extremities is established by administration of neurotoxin to the stellate ganglion, i.e. affecting the inferior, middle and superior cervical sympathetic nerves (see paragraph 0021; meets limitations of claim 39, 42-43 and 68). Moreover, the toxin induced sympathetic block is used to treat cardiovascular conditions that are improved by an interruption of sympathetic stimulation, e.g. hypertension, and other conditions where sympathetically induced vasoconstriction adversely affects a patient's health. In yet another embodiment, the toxin induced sympathetic block is used to treat conditions characterized by smooth muscle spasms, some of which smooth muscles may be arterial, e.g. in the treatment of cerebral vasospasm, coronary vasospasm, peripheral vasospasm and the like (see paragraph 0022; meets claims 42, 51, 53, and 67). Further, the botulinum toxin is botulinum toxin type A. In a preferred embodiment, the botulinum toxin is administered as a complex, in order to enhance the stability of the toxin (see paragraph 0032; meets claims 40, 44 and 55). The effective dose is from about 1 to 300 units (see claim 3; meets claims 45-47 and 61-63). Carroll discloses that treatment with an analgesically effective dose of toxin is performed by injection of the dose in the retroperitoneal space at the border of the ganglion or vertebral body. The injection may be performed with a single or divided dose. Fluoroscopic guidance may be used to aid in the procedure (see paragraph 0056; meets claims 41, 43 and 57). Further, the term “unit dosage forms” refers to physically discrete units suitable as unitary dosages for a human subject. Each unit contains a predetermined quantity of active material calculated to produce the desired onset, tolerability, and therapeutic effects, in association with a suitable pharmaceutical excipient (e.g., an ampoule) (see paragraph 0037; meets limitation of claims 45-47 and 61-63). Anesthetics of interest for the methods of the invention include lidocaine. These agents are used at conventional doses, as known in the art (see paragraph 0044; meets claims 53-54). The toxin may be administered as a pharmaceutical formulation of one or a combination of toxins and may further comprises a corticosteroid routinely administered orally or by injection. In another embodiment, the pharmaceutical formulation further comprises a local anesthetic, as described above (see paragraph 0049; meets claim 53). Lastly, other cardiovascular conditions can be related to atherosclerosis, e.g. coronary artery disease, which may be aided with a block of the sympathetic trunk; and post prandial ischemia, which may be aided by a celiac plexus block. Additional cardiovascular conditions include essential hypertension, which may be aided with a block of the sympathetic ganglion in the celiac plexus, aortorenal ganglion; lumbar sympathetic ganglion; and celiac ganglion (see paragraph 0060; meets claims 50, 66 and 68). Applicant argues that: 1) To expedite prosecution the rejected independent claims are amended herein to specify injection into the stellate ganglion. Carroll administers into the retroperitoneal space at the border of the ganglion rather than the ganglion itself. Applicant’s arguments have been fully considered, but are deemed non-persuasive. With regard to Point 1, while there is a passage describing the administration of a neurotoxin into the retroperitoneal space at the border of the ganglion; Applicant should not ignore or negate the other embodiments Carroll does disclose. Carroll specifically discloses that the toxin induced sympathetic block is used to treat cardiovascular conditions that are improved by an interruption of sympathetic stimulation, e.g. hypertension, and other conditions where sympathetically induced vasoconstriction adversely affects a patient's health. The toxin induced sympathetic block is used to treat conditions characterized by smooth muscle spasms, some of which smooth muscles may be arterial, e.g. in the treatment of cerebral vasospasm, coronary vasospasm, peripheral vasospasm and the like. Within the same scope, Carroll specifically discloses that to create said block, a block of the upper extremities is established by administration of neurotoxin to the stellate ganglion, i.e. affecting the inferior, middle and superior cervical sympathetic nerves. Paragraphs 21 and 22 are copied below for your convenience. PNG media_image1.png 215 300 media_image1.png Greyscale PNG media_image2.png 43 300 media_image2.png Greyscale Therefore, the Office takes the position that taken as a whole Carroll remains anticipatory of the invention as claimed. Thus, the rejection is thereby maintained for the reasons set forth in the previous Office action. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 4. The rejection of claim(s) 56 under 35 U.S.C. 103 as being unpatentable over Carroll et al., US 2007/0264373 A1; Published: Nov. 15, 2007 is maintained for the reasons set forth in the previous office action. Dependent claim 56 is drawn to a method a claimed wherein said administration comprises locating the cricoid cartilage of the larynx to identify the location of the stellate ganglion and injecting into the stellate ganglion or vicinity thereof. Carroll teaches methods to extend sympathetic nerve block, by administration of a neurotoxin at and/or around a targeted sympathetic ganglion. A preferred neurotoxin is a botulinum toxin, e.g. serotypes A, B, C1, D, E, F and G. The neurotoxin may be administered percutaneously as one or a cocktail of serotypes; and is optionally combined with a local anesthetic, anti-inflammatory agent, and the like (see paragraph 0019; meets limitations of claim 39, 42-43 and 68). In one embodiment of the invention, the toxin used to induce sympathetic block is used for the treatment of sympathetically maintained pain. In this method, the involvement of sympathetic nerves may be initially diagnosed through a short term sympathetic block, for example by administration of an IV adrenergic antagonist; percutaneous administration of local anesthetic near the sympathetic ganglion or chain, and the like. Following confirmation of sympathetic involvement in pain, the neurotoxin is administered to the targeted sympathetic ganglion (see paragraph 0020; meets limitations of claim 39, 42-43 and 68). In one embodiment, a block of the upper extremities is established by administration of neurotoxin to the stellate ganglion, i.e. affecting the inferior, middle and superior cervical sympathetic nerves (see paragraph 0021; meets limitations of claim 39, 42-43 and 68). Moreover, Carroll teaches that the toxin induced sympathetic block is used to treat cardiovascular conditions that are improved by an interruption of sympathetic stimulation, e.g. hypertension, and other conditions where sympathetically induced vasoconstriction adversely affects a patient's health. In yet another embodiment, the toxin is induced sympathetic block is used to treat conditions characterized by smooth muscle spasms, some of which smooth muscles may be arterial, e.g. in the treatment of cerebral vasospasm, coronary vasospasm, peripheral vasospasm and the like (see paragraph 0022; meets claims 42, 51, 53, and 67). Further, the botulinum toxin is botulinum toxin type A. In a preferred embodiment, the botulinum toxin is administered as a complex, in order to enhance the stability of the toxin (see paragraph 0032; meets claims 40, 44 and 55). The effective dose is from about 1 to 300 units (see claim 3; meets claims 45-47 and 61-63). Treatment with an analgesically effective dose of toxin is performed by injection of the dose in the retroperitoneal space at the border of the ganglion or vertebral body. The injection may be performed with a single or divided dose. Fluoroscopic guidance may be used to aid in the procedure (see paragraph 0056; meets claims 41, 43 and 57). The term “unit dosage forms” refers to physically discrete units suitable as unitary dosages for a human subject. Each unit contains a predetermined quantity of active material calculated to produce the desired onset, tolerability, and therapeutic effects, in association with a suitable pharmaceutical excipient (e.g., an ampoule) (see paragraph 0037; meets limitation of claims 45-47 and 61-63). Anesthetics of interest for the methods of the invention include lidocaine. These agents are used at conventional doses, as known in the art (see paragraph 0044; meets claims 53-54). The toxin may be administered as a pharmaceutical formulation of one or a combination of toxins and may further comprises a corticosteroid routinely administered orally or by injection. In another embodiment, the pharmaceutical formulation further comprises a local anesthetic, as described above (see paragraph 0049; meets claim 53). Lastly, other cardiovascular conditions can be related to atherosclerosis, e.g. coronary artery disease, which may be aided with a block of the sympathetic trunk; and post prandial ischemia, which may be aided by a celiac plexus block. Additional cardiovascular conditions include essential hypertension, which may be aided with a block of the sympathetic ganglion in the celiac plexus, aortorenal ganglion; lumbar sympathetic ganglion; and celiac ganglion (see paragraph 0060; meets claims 50, 66 and 68). Carroll do not specifically teach that their administration comprises locating the cricoid cartilage of the larynx to identify the location of the stellate ganglion and injecting into the stellate ganglion or vicinity thereof. It would have been obvious before the effective filing date of the presently claimed invention to locate the cricoid cartilage of the larynx to identify the location of the stellate ganglion and then inject into the stellate ganglion or vicinity thereof with a reasonable expectation of success because it is obvious to one of ordinary skill in the art to use fluoroscopy to locate the cricoid cartilage of the larynx to identify properly the location of the stellate ganglion. The skilled artisan would have been motivated to make this modification because of the prior art teaches (at paragraph 0056) that the injection may be performed with a single or divided dose and that Fluoroscopic guidance may be used to aid in the procedure. Accordingly, the subject matter of claim 56 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary. Applicant argues that: 1) Applicant has amended claim 53, and as noted previously, Carroll administers into the retroperitoneal space at the border rather than the ganglion itself. Applicant’s arguments have been fully considered, but are deemed non-persuasive. With regard to Point 1, for the reasons explained above, Carroll remains an appropriate obvious rejection and is therefore maintained. New Grounds of Objection and Rejection Claim Objections 5. Claims 42, 49 and 65 are objected to because of the following informalities: As it pertains to claim 42, after ‘comprising’ the semicolon should be a colon. As it pertains to claims 49 and 65, said claim depends upon a rejected based claim. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 6. Claim 56 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 56 recites in part, ‘wherein said administration comprises locating the cricoid cartilage of the larynx to identify the location of the stellate ganglion’. Said claim is rendered vague and indefinite by the use of the phrase “wherein said administration comprises locating the cricoid cartilage of the larynx to identify the location of the stellate ganglion’. It is unclear what is meant by said phrase, as it is not explicitly defined in the specification. First, there are two administration steps in the claim which it depends; a toxin and a local anesthetic. Which administration is sufficient to locate the cricoid cartilage? Secondly, it is unclear how the administration of either a botulinum toxin or local anesthetic aids in locating the cricoid cartilage of the larynx to identify the location of the stellate ganglion. As written, it is impossible to determine the metes and bounds of the claimed invention. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 7. Claim(s) 39-48, 51, 58 and 59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al., Heart Rhythm, 2019;16(5): supp. S-PO05-059. Independent claim 39 is drawn to a method of treating a cardiovascular disorder comprising: administering a botulinum toxin into the stellate ganglion of a mammal to treat at least one of angina, arrhythmias of heart rate, a myocardial contractility disorder, coronary artery disease, and high blood pressure; thereby reducing the occurrence of at least one symptom of the disorder. Independent claim 42 is drawn to a method of treating a cardiovascular disorder comprising: administering a botulinum toxin into the stellate ganglion in a subject with a cardiovascular disorder to thereby treat their symptoms. Independent claim 43 is drawn to a method of treating a cardiovascular disorder comprising administering a botulinum toxin into the stellate ganglion wherein the administration is performed by imaging the treatment area. Yu et al. disclose that stellate ganglion suppression has been shown to prevent ventricular arrhythmias (VAs). Botulinum toxin type A (BTA) is a typical neurotoxin that can effectively block the ganglion. Further, Yu discloses that their method uses ultrasound guided percutaneous microinjection of BTA to block the left stellate ganglion (LSG) and prevent ischemia-induced VAs. Specifically, 50U/0.25ml BTA was microinjected into LSG percutaneously under the guidance of ultrasound. Compared with the control group, BTA significantly inhibited LSG function and neural activity, and prolonged ventricular ERP from 3 hours up to 5 hours post-BTA microinjection. Particularly, BTA microinjection into LSG significantly suppressed ischemia-induced VAs. The ischemia-induced nerve growth factor and c-fos overexpression were also significantly down-regulated by BTA. In addition, the tunnel staining showed no significant difference between the two groups. In conclusion, ultrasound-guided percutaneous microinjection of BTA could block LSG neural activity and prevent the ischemia induced Vas (see all of S-PO05-059; meets claims 39-48 and 58). As it pertains to claim 51, the method steps as claimed are identical to that of the prior art, the cardiovascular disorder, absent evidence to the contrary, necessarily comprises high blood pressure, which are closely linked, as high blood pressure caused structural changes in the heart that trigger fast-paced rhythm abnormalities as well as the fact that an increase in blood pressure, by any means, can induce ventricular arrhythmias. As it pertains to claim 59, Yu discloses the treatment of arrhythmias of heart rate, the method steps are identical and therefore, absent evidence to the contrary, treating arrhythmia necessarily comprises stabilizing ventricular rhythm or reducing tachycardia symptoms. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 8. Claim(s) 53-64 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al., Heart Rhythm, 2019;16(5): supp. S-PO05-059 as applied to claims 39-48, 51 and 58 above, and further in view of Tian et al., Circ Arrhythm Electrophysiol., 2019; 12(e007118):1-8; and evidenced by Piraccini et al., Stellate Ganglion Blocks, NCBI Bookshelf, 2023; StatPears [Internet]. Yu teaches the limitation as set forth supra. Yu does not specifically teach an administration of a local anesthetic to the stellate ganglion nerve, as recited in claim 53 or that said local anesthetic comprises lidocaine, as recited in claim 54; nor does it specifically teach imaging comprising fluoroscopy or ultrasound, as recited in claims 57-58. Tian teaches that bupivacaine, alone or combined with lidocaine, was injected into the neck with good local anesthetic spread in the vicinity of the left stellate ganglion or both stellate ganglia. Percutaneous SGB may be considered for stabilizing ventricular rhythm in patients for whom other therapies have failed. Ventricular arrhythmia (VA) is a common and potentially lethal clinical event in patients with or without heart disease. Clustered episodes of ventricular tachycardia (VT) or ventricular fibrillation (VF), also known as electrical storm (ES)Studies showed that the autonomic nervous system has an important role in the triggering and maintenance of VA,4,5 especially in ES.3 Therefore, suppressing sympathetic activity may be imperative for controlling VA. The burden of VA may be reduced by cardiac sympathetic intervention by unilateral left or bilateral stellate ganglion blockade (SGB) through pharmacological infiltration or by left cardiac sympathetic denervation through surgical resection of the extrinsic sympathetic chain. Urgent surgical left cardiac sympathetic denervation, however, is difficult to perform in patients with ES. Ultrasound-guided percutaneous SGB—a bedside procedure—is an alternative and possibly effective therapy for the management of ES (see abstract and page 2). Further, Tian teaches that during the SGB procedure the operator can make the decision to use ultrasonography guided or fluoroscopy-guided SGB, and the anesthesiologist and clinician caring for the patient makes the decision to perform unilateral or bilateral SGB (see page 2; SGB Procedure). All pertinent structures were identified by ultrasonography (carotid artery, left internal jugular vein, longus coli muscle, vertebral artery, anterior scalene muscle, and brachial plexus). The skin was anesthetized with 2 mL of 1% lidocaine. A 22-gauge, 2-inch spinal needle (Pajunk) was advanced in-plane in a posterior-to-anterior direction to the anterior surface of the longus coli muscle to avoid all vascular structures. After a negative aspiration, local anesthetic agents were injected incrementally. The stellate ganglion was visualized lifting off the anterior aspect of the longus coli muscle (Figure 1) (see page 3; Ultrasonography-Guided SGB). The anterolateral points of entry on the skin, targeting the uncinate processes of C6 bilaterally, were infiltrated using 1% lidocaine. Care was taken to avoid puncturing any preexisting appliances in the neck. Under fluoroscopic guidance, a 3.5-inch, 25-gauge spinal needle was advanced to gently contact the uncinate process/base of the trans verse process. After a negative aspiration, 0.5 mL of contrast media was injected, which had to show a nonvascular spread pattern in the region of the stellate ganglion. Next, local anesthetic agents were slowly and incrementally injected after frequent negative aspirations (see page 3; Fluoroscopy-Guided SGB). A total of 38 SGB procedures were performed in 30 patients (4 patients underwent 2 and 3 patients underwent 3 SGB procedures), of which 30 procedures were guided by ultrasound and 8 were guided by fluoroscopy. After the stellate ganglion was identified, the anesthetic agent was injected (Table 2)(see page 5; SGB Procedures). As it pertains to claim 56, the Office takes the position that the use of the cricoid cartilage to identify the location of the stellate ganglion is a routine step in the claimed procedure as evidenced by Piraccini, which teaches that SGB is used for the treatment of many medical conditions including complex regional pain syndrome and peripheral vascular disease. Also noting that historically, the anesthetic has been injected at the C6 or C7 vertebral level with the Chassignac’s tubercle, the cricoid cartilage, and the carotid artery serving as the anatomic landmarks to the procedure (see continuing education activity). It would have been obvious before the effective filing date of the presently claimed invention to employ a local anesthetic and imaging resources when administering botulinum toxin to or in the vicinity of the stellate ganglion in methods suggested by Yu et al. with a reasonable expectation of success. This modification may be viewed as a combining of elements known in the prior art where one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. See the recent Board decision Ex parte Smith,--USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396). The skilled artisan would have been motivated to make this modification because Tian suggests these particular steps, particularly, using ultrasound under fluoroscopic guidance-a bedside procedure- to identify the stellate ganglion and to ensure comfort, to see all pertinent structures, and to gently execute the procedure. Accordingly, the subject matter of the rejected claims would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary. Conclusion 8. No claim is allowed. 9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LAKIA J JACKSON-TONGUE/ Examiner, Art Unit 1645 February 27, 2026 /DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645
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Prosecution Timeline

Sep 12, 2022
Application Filed
Mar 24, 2025
Examiner Interview (Telephonic)
Apr 22, 2025
Non-Final Rejection mailed — §102, §103, §112
Jul 22, 2025
Response Filed
Oct 21, 2025
Final Rejection mailed — §102, §103, §112
Jan 21, 2026
Request for Continued Examination
Jan 27, 2026
Response after Non-Final Action
Apr 01, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
69%
Grant Probability
89%
With Interview (+20.4%)
3y 2m (~0m remaining)
Median Time to Grant
High
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